Mental Practice Efficacy in Stroke-Induced Hemiparesis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT01026896
First received: December 4, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

This study will examine whether mentally rehearsing moving one's affected arm after stroke will improve the quality and amount of affected arm movement. The study will enroll 100 people who have experienced a stroke > 1 year ago, and who still have difficulty moving their affected wrists and hands. Eligible subjects also cannot have any implanted devices or metal above the waist. Each patient will receive 10 weeks of therapy targeting their affected arms. Half of the subjects will also be administered mental rehearsal of the exercises that they are physically performing, while the other half will be administered stroke information and information on additional exercises that they can perform targeting their affected arms. Tests of arm movement and use will be given before and after intervention, as well as 3 months after intervention, to measure response to these interventions. We will also administer brain scans before and after intervention. We hypothesize that people receiving the mantal and physical rehearsal will show larger arm movement and use changes.


Condition Intervention Phase
Stroke-induced he,Iparesis in the Arm
Behavioral: Affected Arm Therapy + Mental Practice
Behavioral: Affected Arm Therapy + Stroke Information
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mental Practice in Chronic Stroke-Induced Hemiparesis

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • The Action Research Arm test [ Time Frame: Twice before intervention phase; once directly after intervention phase; once 3 months after intervention phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Affected Arm Therapy + Mental Practice Behavioral: Affected Arm Therapy + Mental Practice
Subjects will be administered 10 weeks of rehabilitative therapy targeting the affected arm. Mental practice of the rehabilitative exercises performed will occur directly after therapy.
Active Comparator: Affected Arm Therapy + Stroke Information Behavioral: Affected Arm Therapy + Stroke Information
Patients will be administered 10 weeks of rehabilitative therapy targeting their affected arms. Directly after their therapy sessions, subjects will be administered information on stroke and exercises targeting their affected arms.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:(1) Minimum motor criteria: able to at least actively flex the affected wrist a minimum of 10 degrees and actively flex the MP joints of the thumb, and at least 2 additional MP joints in two additional fingers at least 10 degrees. These movements must be repeated at least 3 times in one minute. Additionally, subjects in this study will have to exhibit the aforementioned active range of motion and a FM score of 28 to be eligible for study inclusion. (2) stroke experienced > 1 year prior to study enrollment; (3) a score > 25 on the Folstein Mini Mental Status Examination (MMSE), (4) age > 21 < 75; (5) have experienced one stroke; (6) discharged from all forms of physical rehabilitation.

Exclusion Criteria:(1) < 21 years old; (2) excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale; (3) excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of > 2 on the Modified Ashworth Spasticity Scale;92 (4) currently participating in any experimental rehabilitation or drug studies; (5) mirror movements (i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand); (6) contraindication to a MRI procedure (i.e., metal implants, claustrophobia)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026896

Locations
United States, Ohio
University of Cincinnati/Drake Center
Cincinnati, Ohio, United States, 45267
MetroHeealth/Cleveland Clinic
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Page, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Stephen J. Page, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01026896     History of Changes
Other Study ID Numbers: Mental Practice in Stroke
Study First Received: December 4, 2009
Last Updated: December 4, 2009
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Mental practice
motor imagery
stroke
hemiplegia
motor recovery
neuroplasticity

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014